A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) (NCT01100502)
This is a randomized, double-blind, placebo-controlled, multicenter phase III trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
- Condition: Lymphoma
- Phase: III
- Enrollment: 329
- Start: April 2010
- Estimated Completion: April 2016
- Last verified: March 2015
- Last updated: April 12, 2016
- Health Authority: United States Food and Drug Administration (FDA)
The AETHERA trial is a randomized, double-blind, phase III study of brentuximab vedotin and best supportive care (BSC) vs. placebo and BSC in Hodgkin lymphoma (HL) patients at increased risk of relapse or progression post-autologous stem cell transplant (ASCT). Early consolidation post-ASCT with brentuximab vedotin demonstrated improved progression-free survival (PFS) per independent review compared with placebo (median PFS 43 vs 24 months; HR = 0.57, p = 0.001). The most common treatment-emergent grade ≥3 adverse events (AEs) were neutropenia (29% brentuximab vedotin vs 10% placebo), peripheral sensory neuropathy (10% vs 1%), thrombocytopenia (4% vs 3%), peripheral motor neuropathy (6% vs 1%) and anaemia (4% vs 2%). Treatment discontinuation due to AEs occurred in 33% vs 6% of patients, and 53 patients died on study (17% vs 16%). 
Last Editorial review: June 10, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.